Safety and Efficacy of Aliskiren on the Progression of Atherosclerosis in Coronary Artery Disease Patients (AQUARIUS)

This study has been completed.
Sponsor:
Collaborator:
The Cleveland Clinic
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00853827
First received: February 26, 2009
Last updated: May 20, 2014
Last verified: May 2014

February 26, 2009
May 20, 2014
March 2009
January 2013   (final data collection date for primary outcome measure)
Change From Baseline in Percent Atheroma Volume(PAV) After 104 Weeks of Treatment [ Time Frame: Baseline, 104 weeks ] [ Designated as safety issue: No ]
Change from baseline in PAV for all matched slices of anatomically comparable segments of the target coronary artery were assessed by intravascular ultrasound (IVUS) evaluation after 104 weeks of treatment . calculation for change is the value at the later time point minus the value at the earlier time point, with positive numbers to represent increases and negative numbers to represent decreases
Change in the progression of coronary atherosclerosis (defined as change from baseline in percent atheroma volume) as assessed by IVUS [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00853827 on ClinicalTrials.gov Archive Site
  • Change in Normalized Total Atheroma Volume (TAV) as Assessed by IVUS [ Time Frame: Baseline, 104 weeks ] [ Designated as safety issue: No ]
    Change from baseline in normalized total atheroma volume (TAV) (mm^3) for all matched slices of anatomically comparable segments of the target coronary artery were assess by IVUS after 104 weeks of treatment. calculation for change is the value at the later time point minus the value at the earlier time point, with positive numbers to represent increases and negative numbers to represent decreases
  • Patients That Demonstrated Evidence of Atheroma Regression [ Time Frame: Baseline to endpoint (104 weeks) ] [ Designated as safety issue: No ]
    Atheroma regression is defined as change from baseline to endpoint in PAV <0 .
  • Number of Patients With Adverse Events, Serious Adverse Events, and Death [ Time Frame: 104 weeks ] [ Designated as safety issue: Yes ]
    overall safety and tolerability of aliskiren 300 mg compared to placebo in patients with CAD and BP in the pre-hypertensive (high normal) range with or without treatment for hypertension following 104 weeks of treatment. Any Adverse Event was defined as occurrence of any symptom regardless of intensity grade, Serious Adverse Event (SAEs) assessed as medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in persistent or significant disability/incapacity.
  • Change in normalized total atheroma volume as assessed by IVUS [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients that demonstrate evidence of atheroma regression (defined as any reduction in percent atheroma volume from baseline) as assessed by IVUS [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
  • Overall safety and tolerability of aliskiren compared to placebo following treatment duration [ Time Frame: 104 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Safety and Efficacy of Aliskiren on the Progression of Atherosclerosis in Coronary Artery Disease Patients
A 104 Week, Randomized, Double Blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy of Aliskiren on the Progression of Atherosclerosis in Patients With Coronary Artery Disease When Added to Optimal Background Therapy

The study will assess the change in coronary atherosclerotic disease as determined by intravascular ultrasound (IVUS) for aliskiren compared to placebo when given in addition to standard therapy in patients with coronary artery disease (CAD) and a blood pressure in the pre-hypertensive range.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Coronary Artery Disease (CAD)
  • Coronary Atherosclerosis
  • Drug: Placebo
    Placebo
  • Drug: Aliskiren
    300 mg
  • Placebo Comparator: 1
    Intervention: Drug: Placebo
  • Experimental: 2
    Aliskiren 300 mg
    Intervention: Drug: Aliskiren
Nicholls SJ, Bakris GL, Kastelein JJ, Menon V, Williams B, Armbrecht J, Brunel P, Nicolaides M, Hsu A, Hu B, Fang H, Puri R, Uno K, Kataoka Y, Bash D, Nissen SE. Effect of aliskiren on progression of coronary disease in patients with prehypertension: the AQUARIUS randomized clinical trial. JAMA. 2013 Sep 18;310(11):1135-44. doi: 10.1001/jama.2013.277169.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
613
January 2013
January 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with CAD who have blood pressure in the pre-hypertensive range defined as a msSBP ≥ 125 and ≤ 139mmHg and a msDBP < 90mmHg.
  • Patients with or without current treatment for hypertension
  • Angiographic evidence of coronary artery disease
  • At least 2 qualifying Cardiovascular risk factors at Visit 1

Exclusion Criteria:

  • Baseline IVUS determined unacceptable
  • Patients requiring treatment with disallowed study medications
  • Patients with clinically significant heart disease
  • Previous or current diagnosis of heart failure (NYHA Class IV) or a documented left ventricular ejection fraction of < 25%
  • Patients requiring treatment with any 2 of the following classes of medication at Visit 1 or Visit 2:

    • Angiotensin converting enzyme inhibitors
    • Angiotensin receptor blockers
    • aldosterone receptor blockers or a direct renin inhibitor.
  • Other conditions may apply
Both
35 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Belgium,   Canada,   France,   Germany,   Hungary,   Italy,   Poland,   Spain
 
NCT00853827
CSPP100A2366, 2008-006447-40
No
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
The Cleveland Clinic
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Study Director: Novartis Novartis
Novartis
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP